Cleared Traditional

CHEMPRO 1000(TM) (K870860) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K870860 · Arden Medical Systems, Inc. · Hematology device
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Apr 1987
Decision
42d
Days
Class 2
Risk

K870860 is an FDA 510(k) clearance for the CHEMPRO 1000(TM). Classified as Instrument, Hematocrit, Automated (product code GKF), Class II - Special Controls.

Submitted by Arden Medical Systems, Inc. (Arden Hills, US). The FDA issued a Cleared decision on April 14, 1987 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5600 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Arden Medical Systems, Inc. devices

Submission Details

510(k) Number K870860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1987
Decision Date April 14, 1987
Days to Decision 42 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 113d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKF Instrument, Hematocrit, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5600
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GKF Instrument, Hematocrit, Automated

All 14
Devices cleared under the same product code (GKF) and FDA review panel - the closest regulatory comparables to K870860.
GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)
K160415 · Instrumentation Laboratory CO · Dec 2016
SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE
K864646 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1987
STAT-CRIT HEMATOCRIT MEASURING INSTRU
K802199 · United States Surgical, A Division of Tyco Healthc · Feb 1981